We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Synchronized Immunization NotifiCations (SINC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02710318
Recruitment Status : Enrolling by invitation
First Posted : March 16, 2016
Last Update Posted : July 21, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Immunization is one of the most effective public health interventions. Yet, nationally coverage has consistently fallen short of national goals, and has remained for the most part stagnant. The continued presence of vaccine-preventable diseases poses a threat to public health. In addition to needed improvement of immunization coverage for the general pediatric/adolescent population, some children with chronic medical conditions need specific additional immunizations, yet many fail to receive them.

Immunization reminders for providers in the electronic health record (EHR) are a type of clinical decision support (CDS) that can reduce missed immunization opportunities. One limitation of these reminders is that they generally depend only on data local to the EHR, which can be incomplete due to record scatter, leading to inaccurate alerts. An Immunization Information System (IIS), also known as an immunization registry, is a population-based system that collects immunization data primarily for children and adolescents from providers at a regional or state level.

The investigators seek to couple bidirectional exchange of IIS immunization information and forecasting tools with patient level medical history from the EHR to deliver accurate, patient-specific EHR immunization reminders.


Condition or disease Intervention/treatment
Vaccination Behavioral: Electronic immunization alert

  Hide Detailed Description

Detailed Description:

National immunization coverage has consistently fallen short of Healthy People 2010 and 2020 goals and has remained relatively stagnant over the past few years for many immunizations. One important group with a high risk of under-immunization are children with chronic medical conditions (CMCs), who are also at increased risk of serious morbidity and even death from vaccine preventable diseases. One of the key interventions to improve immunization coverage in both the general population and children with CMCs is to decrease missed opportunities for immunization. Immunization reminders in the electronic health record (EHR) are a type of clinical decision support (CDS) that can reduce missed opportunities. In a recent project, the investigators successfully employed such reminders to increase influenza immunization.

One limitation of EHR immunization reminders is that they generally act only on local EHR immunization data. If that data is incomplete, a provider may be erroneously alerted to order an immunization the child does not need. The likelihood of incomplete local data is high. Nearly one-quarter of children in the U.S. visit more than one immunization provider in their first three years of life, leading to fragmented and incomplete records. Low-income and minority children are especially susceptible to immunization record fragmentation as they are more likely to receive care from multiple clinics and providers. Children with CMCs are also at high-risk since their care is often shared between a primary care provider and subspecialists.Harnessing Immunization Information Systems (IIS) data can help overcome this limitation. IIS are population-based systems that collect immunization data primarily for children and adolescents from providers at a regional or state level, consolidating patient's immunization data into a single location no matter where administered. There are currently IIS in 50 states, five cities, and the District of Columbia. However, in most cases, IIS data are available to providers only on the IIS's website. Yet, frontline care providers are most likely to benefit when an IIS provides information at point of patient care within their EHR workflow. This type of bidirectional exchange of immunization information between IIS and EHR systems is a proposed Stage 3 Meaningful Use objective; this consolidated data would be the most complete data to use for an EHR reminder, but is rarely used.

Another challenge associated with EHR-based immunization reminders is that pediatric and adolescent immunization schedules are complex, requiring up to 35 immunizations plus the annual influenza vaccine. Each immunization series has its own minimum age and dosing intervals, and new immunizations are not uncommon. However, many EHRs may not have or aggressively maintain comprehensive immunization decision rules.

IIS can help overcome this limitation as well. Many include tools for forecasting when doses are next due and can provide that information during data exchange with an EHR, but that has not been assessed.

Bringing IIS immunization data and forecasting tools into a local EHR to power CDS will be helpful for the general population. However, one limitation of immunization CDS, whether provided by an IIS or native to the EHR, is that it does not account for subtleties required by children with certain CMCs who may need extra immunizations specific to their condition or cannot receive certain immunizations. A logical next-step is to couple exchange of IIS immunization data and forecasting tools with patient-level EHR information regarding medical conditions to power accurate, patient-specific EHR immunization reminders. This has yet to be done.

Aim 1: Assess the impact of EHR reminders integrated with immunization data and forecasting from a regional IIS on receipt of generally recommended immunizations in a low-income, urban, pediatric and adolescent population.

Aim 2: Assess the impact of integrated EHR reminders that also incorporate patient's medical conditions on receipt of immunizations specifically recommended for children and adolescents with chronic medical conditions.

Hypothesis 1: Lower rates of under-immunization will be observed when reminders are 'on' vs. 'off'.

Hypothesis 2: Lower rates of over-immunization will be observed when reminders are 'on' vs. 'off'.

Hypothesis 3: Higher rates of captured opportunities will be observed when reminders are 'on' vs. 'off'.

Hypothesis 4: There will be no difference in reminder impact on generally recommended immunizations for children with and without chronic medical conditions (CMCs)

In this three-year project, investigators will conduct a randomized cluster crossover pragmatic clinical trial to assess immunization outcomes during periods when an integrated immunization reminder is 'on' vs. 'off' for generally recommended immunizations as well as ones specific for children with CMCs. The proposed work will generate empiric knowledge regarding the best practices for implementing IIS-supported immunization reminders for both children with and without CMCs. The results may help guide local and national efforts on both immunization data exchange and EHR reminders.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Synchronized Immunization NotifiCations
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018
Arms and Interventions

Arm Intervention/treatment
Experimental: Immunization Alert on
Children with visits seen when the immunization alert is on
Behavioral: Electronic immunization alert
Immunization alert in the electronic health record
No Intervention: Immunization Alert off
Children with visits seen when the alert is off


Outcome Measures

Primary Outcome Measures :
  1. Under-immunization- general recommendations [ Time Frame: 1 day ]
    Percent of children and adolescents seen during the study periods who are overdue for at least one age appropriate immunization as recommended by the CDC's Advisory Committee on Immunization Practices

  2. Under-immunization- recommendations for children with chronic medical conditions [ Time Frame: 1 day ]
    Percent of children and adolescents with a chronic medical condition for which a specific additional immunization is recommended who are seen during the study periods who are overdue for at least one of these specific immunizations

  3. Over-immunization [ Time Frame: 1 day ]
    Percent of children who have received at least one immunization in excess of the recommended immunizations for their age or condition


Secondary Outcome Measures :
  1. Captured opportunity [ Time Frame: 1 day ]
    Proportion of medical visits in the analytic period during which a child/adolescent was eligible for an immunization, and received it


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • medical visit at study site during analytic period

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710318


Locations
United States, New York
Columbia University Medical Center/ NewYork Presbyterian Hospital Ambulatory Care Network
New York, New York, United States, 10032
United States, Washington
Seattle Children's Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Columbia University
New York Presbyterian Hospital
Seattle Children's Hospital
Investigators
Principal Investigator: Melissa Stockwell, MD MPH Columbia University
More Information

Responsible Party: Melissa Stockwell, Associate Professor of Pediatrics and Population and Family Health, Columbia University
ClinicalTrials.gov Identifier: NCT02710318     History of Changes
Other Study ID Numbers: AAAP6516
First Posted: March 16, 2016    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs